Quality Assurance Associate - 3rd Shift (AQL & Batch)

Actalent; Portage (IN); On-site; USD 33,000 - 45,000; Full time

Job summary

Actalent is seeking an MQA Quality Associate for the 3rd shift (12pm–8am) in Portage, IN. You will assist with AQL testing, batch record review and release, CAPAs and investigations, and line clearances to ensure proper changeovers and material accuracy.

Responsibilities include sampling, testing, results recording, and coordinating with QA and operations. Onsite role with contract-to-hire potential; pay range $23.90–$33.00/hr.

Qualifications

• High School Diploma.
• 2+ Years of experience in quality control/assurance, batch record review, AQL testing, auditing, engineering, process improvement preferred.

Responsibilities

• Pull AQL samples during packaging of finished products based on sampling instructions.
• Perform AQL testing by verifying appearance, weight, dimensions of pouch and strip, presence of print on strip and pouch, and seal integrity for each AQL sample pulled.
• Record results from each AQL test performed.
• Communicate AQL alert, action, or failure limits to the Quality Assurance and Operation Supervisor.
• Segregate impacted population criteria based on AQL testing results and communicate criteria to the Operations Supervisor and packaging operators.
• Perform stability sampling, finished product sampling, micro and in-process sampling, and transport samples to the lab per protocol.
• Demonstrate a good understanding of AQL procedures and guidelines after applicable training.
• Perform other duties as instructed by QA Supervisors.
• Train and perform batch record reviews during production operations, line clearance and control procedures, IPC testing, scale/balance verification, and other assigned production support duties.
• Monitor all operations related to manufacturing to ensure adherence to AQST policies and procedures.
• Conduct routine internal audits and facility walkthroughs to ensure compliance with internal quality system requirements.
• Initiate nonconformances and project manage to resolve quality issues by partnering with other functions.
• Author and review Forms, Batch Records, WI, SOPs, and Protocols in the electronic document management system.
• Coordinate the Environmental Monitoring program, including scheduling of third-party water testing, sampling, and report generation.
• Serve as a short to medium-term (3-12 months) project owner for quality projects to improve efficiency or compliance profile.
• Understand the manufacturing schedule and provide quality support to ensure business continuity.
• Operate with a sense of urgency in a fast-paced environment.
• Perform real-time review of operational records, including Batch Records, and assist in obtaining required corrections.

Skills

Quality control

AQL testing

Batch record review

Auditing

Process improvement

Engineering

Education

High School Diploma

Job description

Actalent is seeking an MQA Quality Associate for the 3rd shift (12pm–8am) in Portage, IN. You will assist with AQL testing, batch record review and release, CAPAs and investigations, and line clearances to ensure proper changeovers and material accuracy.

Responsibilities include sampling, testing, results recording, and coordinating with QA and operations. Onsite role with contract-to-hire potential; pay range $23.90–$33.00/hr.